Paravertebral Block for Breast Surgery

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131170
• Other study ID #: PVB1
• Status: Completed
• Phase: Phase 4
• First received: August 15, 2005
• Last updated: July 4, 2007
• Start date: September 2005
• Est. completion date: September 2006

Study information

• Verified date: July 2007
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

The effect of paravertebral block in combination with general anaesthesia is studied in a double blind fashion.

Description:

Patients having surgery for breast cancer receive a paravertebral blockade at C8-Th4 with either Naropin 0.5% or saline. General anaesthesia is then provided with laryngeal mask intubation, propofol infusion and fentanyl i.v. as needed. The effect on postoperative pain ([VAS] and fentanyl PCA doses taken) and postoperative nausea and vomiting is recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Breast surgery

Exclusion Criteria:

• Infections

• Coagulation disorder

• Allergy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• paravertebral block

Locations

Country	Name	City	State
Denmark	Dept of Anesthesiology, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nausea and vomiting 2 hours postoperatively, and 1 and 2 days postoperatively		2 days
Secondary	Dosage of analgesic		1 day